Outsourcing

The company has installed and validated new instruments for structural analysis of proteins.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board. The Pharma & Biopharma Outsourcing Association (PBOA) has announced that Nelson Patterson, vice-president, sales and marketing at Baxter BioPharma Solutions, has been elected to its Board of Trustees, effective immediately. Patterson was elected after Baxter BioPharma Solutions joined the PBOA as a Sustaining Member.

There are significant differences between small molecules and biologics fill/finish capacity.

Bayer has appointed Cardinal Health as US-based contract manufacturer for Xofigo (radium Ra 223 dichloride) injection, and Cardinal Health will build a dedicated facility.

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

The authors present a validation study of an analytical method for the simultaneous determination of nine human cytokines in human K2-EDTA plasma.

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

European CDMOs want into the US market, but entry options are limited.

The trend of exits from the CMO industry looks to be gaining momentum.

Multidirectional collaboration is critical for the new pharma business model; cloud-based information services can offer a communications alternative.

John S. Ross, executive vice president at Metrics Contract Services, provided commentary on the evolving role of contract services in solid/semi-solid dosage development and manufacturing.

Experts at Catalent Pharma Solutions provided commentary on the evolving role of contract services in analytical services, biologics drug development and manufacturing, and solid/semi-solid dosage development and manufacturing.

Experts from PPD provided commentary on the evolving role of contract services in analytical services.

Franco Negron, vice president of North America operations and integration at Patheon Inc., provided commentary on the evolving role of contract services in solid/semi-solid dosage development and manufacturing.

Mark Rogers, senior vice president at SGS Life Science Services, provided commentary on the evolving role of contract services in analytical services.

Experts at Dr. Reddy's CPS provided commentary on the evolving role of contract services in biologics drug development and manufacturing, and solid/semi-solid development manufacturing.

Peter Soelkner, general manager at Vetter Pharma International GmbH, provided commentary on the evolving role of contract services in parenteral drug development and manufacturing.

Andrew Strong, president and CEO of Kalon Kalon Biotherapeutics, provided commentary on the evolving role of contract services in biologics drug development and manufacturing.

Ron Connolly, vice president of commercial operations at Frontage Labs, provided commentary on the role of contract services in analytical services.

Experts at Xcelience provided commentary on the evolving role of contract services in analytical services and solid/semi-solid development manufacturing.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.